Acupuncture for Mucositis Pain in Cancer Care

This study has been withdrawn prior to enrollment.
(Inadequate funding)
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00549835
First received: October 24, 2007
Last updated: August 13, 2009
Last verified: August 2009
  Purpose

This research is being done to see if acupuncture helps relieve mucositis pain in patients with leukemia who are undergoing chemotherapy. Many patients receiving chemotherapy develop mucositis (painful sores or blisters in the mouth or throat). Mucositis is not only a frequent complication in cancer care and extremely painful, but also increases the risks of infection and malnutrition and often leads to discontinuing or delaying the chemotherapy treatments.


Condition Intervention
Mucositis
Pain
Leukemia
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Mucositis Pain in Cancer Care

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Detailed Description:

Acupuncture is one of the oldest, most commonly used medical procedures in the world. The practice originated in China more than 2,000 years ago, and is widely used by doctors in Korea, China, Japan, and other countries to ease pain or various symptoms. In the past two decades, acupuncture has grown in popularity in the United States, and by 2002, an estimated 8.2 million adults in the US report having used acupuncture.

The term acupuncture describes a family of procedures involving stimulation of anatomical points on the body by a variety of techniques. The acupuncture technique that has been most studied scientifically involves penetrating the skin with thin, solid, metallic needles that are manipulated by the hands or by electrical stimulation. Acupuncture needles are metallic, solid, and hair-thin. People experience acupuncture differently, but most feel no or minimal pain as the needles are inserted. Some people are energized by treatment, while others feel relaxed.

Acupuncture has been used to ease some cancer treatment-related side effects such as nausea and vomiting. In this study we will assess the potential usefulness of acupuncture to ease the pain associated with mucositis.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed with leukemia (such as acute myelogenous leukemia) and receiving chemotherapy for induction, consolidation or re-induction or high dose preparative regimen for bone marrow transplantation in the Johns Hopkins Oncology Inpatient Services
  • Participation in standard leukemia-treatment regimens
  • Expectation of survival of three weeks for completion of the study

Exclusion Criteria:

  • Acupuncture treatment within the previous 6 weeks
  • Unable to achieve platelet count of at least 10,000 with platelet support
  • Radiation therapy within one month of enrollment
  • Pregnant women
  • History of substance abuse, including alcohol and IV drug users
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549835

Locations
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Adrian S Dobs, MD MHS Johns Hopkins University
Study Director: Sanghoon Lee, KMD PhD LAc Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00549835     History of Changes
Other Study ID Numbers: NA_00008179
Study First Received: October 24, 2007
Last Updated: August 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
mucositis pain
cancer
pain
acupuncture
mucositis
cancer pain

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 18, 2014